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NCT Number: NCT06808750

Performance of Tests for Schistosoma Haematobium Diagnosis

Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Many years of control interventions and mass drug administration have reduced substantially the prevalence and infection intensities in several areas. In areas with an infection prevalence <10%, the WHO suggests to continue population preventive chemotherapy with praziquantel at the same or reduced frequency, or to use a clinical approach of test-and-treat. In areas that have achieved interruption of transmission, elimination needs to be validated and post-elimination surveillance be implemented.

For determination of infection prevalence thresholds, for test-and-treat, for validation of elimination and for pre- and post-elimination surveillance, reliable diagnostic tools are needed.

In a single-centre study conducted in Pemba, United Republic of Tanzania, the investigators aim to assess the accuracy and performance of standard and new diagnostic tests for S. haematobium diagnosis for use in elimination settings.

The primary objective of the study is to assess the sensitivity and specificity of all investigated diagnostic tests, using the S. haematobium egg count results of five urine filtrations conducted on five urine samples collected over five consecutive days as reference test.

Secondary objectives are:

* To assess the sensitivity and specificity of all investigated diagnostic tests, using latent class analyses. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated as mean egg count derived from the egg counts in five urine samples collected over 5 consecutive days. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated from the egg counts of the urine sample that was analysed with the respective test and urine filtration. * To assess the sensitivity and specificity of all investigated diagnostic tests, using the results of the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) as reference test. * To assess the sensitivity and specificity of all investigated molecular diagnostic tests, using the results of the qPCR as reference test. * To assess the cost and time needed for the implementation of single or multiple-throughput tests.

Our study will evaluate the accuracy and performance of diagnostic tests, in a formerly highly endemic setting that is now approaching elimination (Pemba), and will hence provide important information about which tests can be recommended for threshold determination, and test-and-treat and surveillance.

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Key information

Conditions

Schistosoma Haematobium Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Helminthiasis Infections Male Urogenital Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Schistosomiasis Schistosomiasis haematobia Trematode Infections Urinary Tract Infections Urogenital Diseases Urologic Diseases Vector Borne Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Public Health Laboratory - Ivo de Carneri (PHL-IdC)

Chake Chake, Pemba Island, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening:

  • Attendance of grade 3, 4, 5, or 6 in study school
  • Randomized to participate in initial screening
  • Written informed consent signed by the parents
  • Written assent signed by the participant if aged12-17 years old

Subjects fulfilling all of the following inclusion criteria are eligible for the diagnostic study:

  • Attendance of grade 3, 4, 5, or 6 in study school
  • Randomized to participate in initial screening
  • Written informed consent signed by the parents
  • Written assent signed by the participant if aged12-17 years old
  • S. haematobium-positive urine filtration result in initial screening OR
  • S. haematobium-negative urine filtration result in initial screening, but randomized for participation in diagnostic study

Exclusion criteria

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the initial screening:

  • Not attending any study school
  • Not attending grade 3, 4, 5 or 6
  • Not randomized to participate in initial screening
  • No written informed consent signed by the parents submitted
  • No written assent signed by the participant if aged12-17 years old submitted
  • S. haematobium-negative urine filtration result in initial screening, and not randomized for participation in diagnostic performance study
  • Clinical significant sever disease

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the diagnostic study:

  • Not attending any study school
  • Not attending grade 3, 4, 5 or 6
  • Not randomized to participate in initial screening
  • No written informed consent signed by the parents submitted
  • No written assent signed by the participant if aged12-17 years old submitted
  • S. haematobium-negative urine filtration result in initial screening, and not randomized for participation in diagnostic performance study
  • Clinical significant sever disease

Treatment and study plan

S. haematobium egg detection by single urine filtration

Diagnostic Test

The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy.

S. haematobium egg detection by quintuple urine filtration

Diagnostic Test

Five urine samples will be collected from children participating in the diagnostic study over five days. Each of the five urine samples collected per participant will be tested with a single urine filtration by human microscopy.

S. haematobium egg detection by artificial intelligence (AI) microscopy

Diagnostic Test

The urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy.

Haematuria assessment using reagent strips

Diagnostic Test

The urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips.

S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA)

Diagnostic Test

The urine samples collected on Day 5 of the diagnostic study will be tested with the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA).

S. haematobium DNA detection by recombinase polymerase amplification assay (RPA)

Diagnostic Test

The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA).

S. haematobium DNA detection by qPCR

Diagnostic Test

The urine samples collected on Day 5 of the diagnostic study will be tested with qPCR

Primary outcomes

  1. Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration

    Time frame: From enrollment to the end of the study after 6 weeks

    The primary endpoint will be the sensitivity of the investigated diagnostic tests to detect S. haematobium related markers by the examination of a single sample.

    The primary outcome variable will be the number of S. haematobium infected individuals detected through each test.

Secondary outcomes

  1. Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).

    Time frame: From enrollment to the end of the study after 6 weeks

    Sensitivity is defined as the proportion of positive test results out of all truly positive samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy).

Other outcomes

  1. Specificity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).

    Time frame: From enrollment to the end of the study after 6 weeks.

    Specificity is defined as the proportion of negative test results out of all truly negative samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy).

  2. Correlation of infection markers.

    Time frame: From enrollment to the end of the study after 6 weeks.

    Correlation of the amount of infection markers measured by each test (human microscopy: number of S. haematobium eggs, AI microscopy: number of S. haematobium eggs, reagent strips: microhaematuria grading, RPA: fluorescence level, UCP-CAA: amount of CAA antigen, qPCR: cycle-threshold values).

  3. Costs of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).

    Time frame: 6 month, from start of orders of equipment and material to end of laboratory work.

    Costs are defined as the financial costs incurred by each test for equipment, consumables, and staff time to perform the test.

  4. Time to conduct each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).

    Time frame: From enrollment to the end of the study after 6 weeks.

    Amount of time spent completing each test.

Sponsors and collaborators

Lead sponsor

Stefanie Knopp

Other

Collaborators

  • Enaiblers AB
  • Erasmus Medical Center
  • Leiden University Medical Center
  • Natural History Museum, United Kingdom
  • Public Health Laboratory Ivo de Carneri

Registry information

Official study title

Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania

Acronym: SchistoBreak-D

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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